Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: ASP8825

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Hokkaido, Japan
  • Hyogo, Japan
  • Kanagawa, Japan
  • Kyoto, Japan
  • Miyagi, Japan
  • Osaka, Japan
  • Saitama, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
• International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study

Exclusion Criteria:

• Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
• Patients with an estimated creatinine clearance <60 mL/min determined using the Cockcroft-Gault formula
• Pregnant or lactating women
• Individuals with serum ferritin <20 ng/mL were also excluded from the trial
• Individuals with movement disorders and/or abnormal neurological findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP8825 group	Drug: ASP8825; Oral; Other Names: gabapentin enacarbil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in IRLS score	IRLS: International Restless Legs Syndrome Scale	Baseline to Week 52
Safety assessed by Vital signs	Blood pressure and pulse rate	Up to Week 52
Safety assessed by Adverse Events		Up to Week 52
Safety assessed by Laboratory tests	Hematology, blood biochemistry, thyroid function test and urinalysis	Up to Week 52
Safety assessed by 12-lead-electrocardiogram		Up to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of responders on ICGl of improvement	ICGI: Investigator-rated Clinical Global Impression of improvement	Up to Week 52
Proportion of responders on PCGI of improvement	PCGI: Patient-rated Clinical Global Impression	Up to Week 52
Change from baseline in PSQI	PSQI: Pittsburgh Sleep Quality Index	Baseline to Week 52
Change from baseline in SF-36v2	SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2	Baseline to Week 52
Change from baseline in RLS-QOL	RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire	Baseline to Week 52
Change from baseline in MOS sleep scale	MOS: Medical outcomes study	Baseline to Week 52
Plasma concentration of gabapentin		Week 12, 28 and 52

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: ASP8825; Restless legs syndrome patients; XP13512
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 8825-CL-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED